Impureza 12 de milrinona (CAS 80047-38-7) representa una impureza orgánica relevante en el perfil de impurezas del activo farmacéutico. Su control es crítico para garantizar la calidad y estabilidad del lote; se detecta y cuantifica rutinariamente mediante HPLC acoplado a detección UV y confirmación por LC-MS y RMN. La identificación estructural y estudios de formación por degradación facilitan establecer límites de especificación y criterios de aceptación conforme a ICH Q3A/Q3B. El seguimiento durante el desarrollo y en estudios de estabilidad permite mitigar riesgos asociados a su presencia y optimizar procesos de síntesis y purificación para cumplir requisitos regulatorios.
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